Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Three weeks of treatment with each insulin (glargine, detemir) in random order, double blind assignment. Doses of glargine and detemir were equivalent and were based upon existing long acting insulin doses. Doses were titrated up to achieve target fasting glucose < 150 mg/dl. Both long acting insulins were given once daily before breakfast.

Reporting Groups

Description

Insulin Detemir

These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.

Insulin Glargine

These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Insulin Detemir

These people receive insulin detemir first, then insulin glargine. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.

Insulin Glargine

These people receive insulin glargine first, then insulin detemir. All subjects received three weeks of therapy with their assigned insulin prior to overnight admission for study.

Total

Total of all reporting groups

Baseline Measures

Insulin Detemir

Insulin Glargine

Total

Number of Participants
[units: participants]

5

5

10

Age
[1][units: participants]

<=18 years

0

0

0

Between 18 and 65 years

5

5

10

>=65 years

0

0

0

Age
[2][units: years]Mean (Standard Deviation)

37
(14)

33
(8)

35
(11)

Gender
[units: participants]

Female

3

4

7

Male

2

1

3

Region of Enrollment
[units: participants]

United States

5

5

10

[1]

Data for all enrolled subjects in this crossover study.

[2]

Data for all enrolled subjects.

Outcome Measures

1. Primary:

Calories Consumed During Test Meal After a 24 Hour Fast. [ Time Frame: Measured after a 24 hour fast, after treatment with study insulin for at least 3 weeks ]